Medelis has been managing immunotherapy studies in oncology since 2008. We work directly with sponsors on the development of clinical strategy (protocol, endpoints, regulatory) and with study execution in this growing field.
Immunotherapy trials in oncology have shown tremendous promise and may represent the most promising cancer treatment approach in the past 50 years. However, with an increase in the volume of immunotherapy studies and molecule combinations, it’s critical for sponsors, sites and investigators — and everyone else working on your immunotherapy trial – to understand how the immune system responds to cancer treatments.
Medelis is at the forefront of immunotherapy research and can:
Serious adverse events (SAEs) in oncology immunotherapy studies are critical to the outcome of the study. For sponsors, CROs and sites who are new to immunotherapy studies, failure to clearly understand how the immune system responds to your treatment could cause an improper evaluation of response data and result in your trial ending prematurely, when the immunotherapy treatment was actually working.
The majority of the serious adverse events in an oncology immunotherapy study will be autoimmune-related, since the body will start attacking itself. Many patients enrolled in these studies have advanced cancers and have failed most treatments, so it’s common for them to have weakened immune systems.
Therapies targeting checkpoint receptors have shown to increase toxicities that can create a unique set of adverse events called immune-related adverse events (irAEs). Research is showing that combinations of different checkpoint inhibitors improve the body’s ability to eradicate cancer, but at the cost of an increase in frequency and severity of irAEs.
Patients undergoing immunotherapy treatments may experience reactions like dermatitis (from rashes to toxic epidermal necrolysis), pancreatitis, immunitis, iridocyclitis, hepatotoxicity, hypophysitis, neuropathies, nephritis and hepatitis. Some patients with underlying autoimmune disorders can experience exacerbations of underlying autoimmune conditions when on therapies blocking CTLA-4 and PD-1. These reactions often start out mild but can become severe and life-threatening if not recognized.
Since multiple studies have shown that there is an association between irAEs and clinical benefit, it’s important to have a comprehensive approach for evaluating and treating SAEs.
For every oncology immunotherapy study we recommend the following:
Early recognition and AE management is critical to allow the patient to continue on the study treatment per the protocol. This can be addressed during site training by educating the study coordinator research nurses about potential immune-related AE symptoms.
Each therapy’s relationship with the AE must be assessed. Recent studies have shown that algorithms designed for specific therapies can help clinicians manage and treat the most common irAEs associated with the treatment. These can often predict the irAE frequency and severity based on dosage and frequency of the treatment.
Adverse event report forms must be designed in a way that addresses the possibility for multiple attributions. For example, if there is more than one drug being given, the case report form (CRF) needs to ask about the AE’s relationship to each individual drug, rather than the study treatment as a whole.
Case report guidelines must include specific instructions for the site on how to record the AE.
The research has made it clear that the preparation for, handling of, and analysis of specific types of SAEs and irAEs are critical for immuno-oncology studies — to accurately measure the success of the treatment, to reduce trial delays that extend timelines and increase costs, and most importantly, to ensure the safety of the patients on protocol.
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